Abstract

Recent years have seen the proliferation of a global industry selling stem cell–based interventions. SCBIs are being marketed around the globe in both low- and high-income countries, including Australia, China, India, Japan, Mexico, and the United States. Per capita, Australia has one of the highest prevalence of clinics selling stem cell products per capita, and its drug regulator, the Therapeutic Goods Administration, has excluded autologous stem cells, which are obtained from the patient's own body, from the regulation of biological drug products. This exemption has enabled rapid growth of a...